Proprioception and Multi Sensory Training After DRF

NCT ID: NCT04820114

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-01-01

Brief Summary

Distal radius fracture is the most common upper extremity fracture with peak incidence among older women after the fifth decade of life. Proprioception is one constituent of a complex Sensory motor control process. Proprioception requires the reception and central integration of incoming afferent signals. Although various sensory and motor deficits have been correlated with significant functional impairment after wrist trauma, limited research exists on the effects of proprioception and multi sensory training after distal radius fracture.

Detailed Description

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients diagnosis of distal radius fracture (aged 18 years and above). Both assessor and statistician will remained blinded.

Standard rehabilitation program for distal radius fracture treatments will received for both the control and experimental groups for a period of 12 weeks. The experimental group, in addition, will received a proprioceptive training program during the same intervention period, which will be conducted twice weekly (24 sessions).

The severity of pain with activity will be measured according to the visual analog scale (VAS). PRWE questionnaire will be used to measure upper extremity function. Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) and proprioception with Joint position sense (JPS) and force sense (FS) testing. All outcome measures will be collected at baseline, immediately following the intervention at 3 weeks and at 12 weeks following the end of the intervention.

Participation in the study will be voluntary and patients will be included if they satisfied specific inclusion criteria.

All procedures will be follow in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration. All participants will sign a written informed consent in accordance with guidelines approved by the local ethics committee.

Conditions

Distal Radius Fracture; Wrist Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Wrist passive mobilizations; Actives exercises; Reeducation for Activity daily life.

Group Type: ACTIVE_COMPARATOR

Wrist exercises

Intervention Type: OTHER

Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation

Experimental group

The experimental group will also carried out a proprioceptive exercise program divided in three phases of 2 weeks per phase.

Group Type: EXPERIMENTAL

Proprioceptive wrist exercises

Intervention Type: OTHER

Exercises for recognition of writs position and thumb force sense.

Wrist exercises

Intervention Type: OTHER

Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation

Interventions

Proprioceptive wrist exercises

Exercises for recognition of writs position and thumb force sense.

Intervention Type: OTHER

Wrist exercises

Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient diagnosis of distal radius fracture.
• Wrist immobilization after lesion (unless 3 weeks)
• Capacity for sing inform concept and understand the exercises

Exclusion Criteria

• Others associate fractures in hand or upper limb
• Wrist ligaments injuries
• Neurological disorder affecting the upper limb
• Have received previous proprioceptive training for upper limb injury.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Raquel Cantero-Téllez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Raquel Cantero-Téllez

Málaga, Málaga, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Raquel Cantero, PhD

Role: CONTACT

cantero@uma.es

0034 951952850

Facility Contacts

Raquel Cantero-Téllez

Role: primary

cantero@uma.es

+34606267101

Other Identifiers

Wrist 1 UMA

Identifier Type: -

Identifier Source: org_study_id